Bionique Stomach Soothing Complex (Bio-E Australia Pty Ltd)
Product Name
Bionique Stomach Soothing Complex
Sponsor
Date of review outcome
Date of publication
Dec-21
Outcome
Medicine continues to be permitted for supply. Batches released from 1 August 2021 must carry a corrected label with a declaration for the presence of sucralose and sugars, and advertising for Helicobacter pylori, Escherichia coli, gastric ulcers and flatulence removed.
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
This medicine contains sucralose and sugars. Consider whether the medicine is right for you if you have allergies or sensitives to these substances. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner.
In addition, seek advice from a suitably qualified health professional if you are or have been taking this medicine to relieve or treat gastric symptoms caused by Helicobacter pylori, Escherichia coli or gastric ulcers. Consider whether the medicine is right for you based on it potentially not working as expected in relation to relieving flatulence.
In addition, seek advice from a suitably qualified health professional if you are or have been taking this medicine to relieve or treat gastric symptoms caused by Helicobacter pylori, Escherichia coli or gastric ulcers. Consider whether the medicine is right for you based on it potentially not working as expected in relation to relieving flatulence.
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The medicine contains sucralose and sugars, neither of which were declared on the label. Sucralose and sugars are required to be declared on the labels of medicines as they may cause adverse reactions in individuals sensitive to such substances.
Additionally, the label and/or leaflet for the medicine advertised its use for eliminating Helicobacter pylori from gastric mucosa (and associated inflammation), inhibiting Escherichia coli adhesion, healing gastric ulcers and relieving ulcer-induced pain, which are serious conditions that require diagnosis, treatment or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. References to these conditions have the potential to lead consumers to delay access to timely medical advice or treatment when required, resulting in adverse outcomes. However, the medicine’s label also warns consumers to seek medical advice if symptoms persist, and the sponsor has removed all stock from stores that referred to these conditions and that did not include the required substance declarations. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Additionally, the label and/or leaflet for the medicine advertised its use for eliminating Helicobacter pylori from gastric mucosa (and associated inflammation), inhibiting Escherichia coli adhesion, healing gastric ulcers and relieving ulcer-induced pain, which are serious conditions that require diagnosis, treatment or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. References to these conditions have the potential to lead consumers to delay access to timely medical advice or treatment when required, resulting in adverse outcomes. However, the medicine’s label also warns consumers to seek medical advice if symptoms persist, and the sponsor has removed all stock from stores that referred to these conditions and that did not include the required substance declarations. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label and/or leaflet for the medicine claimed uses for eliminating Helicobacter pylori from gastric mucosa (and associated inflammation), inhibiting Escherichia coli adhesion, healing gastric ulcers, relieving ulcer-induced pain and relieving flatulence. However, these claims were not covered by the sponsor’s certification that they held evidence to substantiate them.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor updated the label to include the statement ‘Contains sucralose and sugars’ and removed the references to Helicobacter pylori, Escherichia coli, gastric ulcers and flatulence.